Folinic Acid in Children With Autism Spectrum Disorders

Autism Spectrum Disorder Clinical Trial

— EFFET  

Official title:

Evaluation of the Efficiency of Folinic Acid in Children With Autism Spectrum Disorders: a Pilot Study "EFFET"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02551380
• Other study ID #: 2015-000955-25
• Status: Recruiting
• Phase: Phase 2
• First received: September 14, 2015
• Last updated: April 6, 2017
• Start date: October 2015
• Est. completion date: January 2018

Study information

• Verified date: April 2017
• Source: Central Hospital, Nancy, France
• Contact: Bruno Leheup, M.D, PH.D
• Phone: +33 3 83 15 45 00
• Email: b.leheup[@]chu-nancy.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigator planned to study the efficiency of folinic acid treatment on autistic symptoms in children suffering from autism spectrum disorder.

Description:

The aim of this study is to realise a pilot study in France in order to evaluate the efficiency of folinic acid in treatment of autism spectrum disorder and get first estimations about prevalence of auto antibodies anti-FRα in France.

The study is a randomized controlled trial monocentric,evaluating folinic acid 10mg per day versus placebo, in single-blind during 12 weeks.

Primary objective : The primary objective is to evaluate the efficiency of folinic acid (calcium folinate) 5mg twice a day during 12 weeks on reduction of autistic troubles, particularly on communication and social interaction

Secondary objective :

• Evaluate the efficiency of folinic acid on reduction of autistic symptoms perceived by parents

• Evaluate the constancy of auto antibodies anti-FRα rates

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 10 Years

Eligibility

Inclusion Criteria:

1. Children with autism spectrum disorders defined by : Autism Diagnostic Observation Schedule (ADOS), Autism Diagnostic Interview (ADI), Childhood Autism Rating Scale (CARS) or diagnosed by a physician (pediatrician, child psychiatrist)

2. Children aged 3 to 10 years

3. Weight> 10 kg

4. Language impairment (based on the medical assessment)

5. Ability to maintain other therapies started before the study

6. No changes of therapeutic treatments within the 8 weeks before the start of the study

Exclusion Criteria:

1. Treatment may impair folate metabolism (methotrexate, anticonvulsivants :

phenobarbital sodium valproate, phenytoin, primidone, carbamazepine, valproic acid, divalproex, antibiotics : tetracycline, trimethoprim, pyrimethamine, inhibitors of proton pump inhibitors of histamine-2)

2. Antipsychotic treatment (including treatment with Risperidone)

3. Vitamin or mineral supplementation exceeding guidelines

4. Children with severe irritability (Aberrant Behavior Checklist> 17)

5. Gastroesophageal reflux disease

6. Any known renal or liver disease

7. Child born premature (<37SA)

8. Known intolerance to lactose

9. Hypersensitivity / allergic reaction to calcium folinate

10. The sibling children with autism spectrum disorders

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive
• Disease

Intervention

Drug:
• FOLINORAL
Folinoral (folinic acid) 5mg twice a day (10 mg per day) during 12 weeks

Other:
• Placebo
Placebo 5mg twice a day (10 mg per day) during 12 weeks

Locations

Country	Name	City	State
France	CHU Nancy-Hopital Brabois Enfants	Vandoeuvre les Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of severity of autistic symptoms with standardized scale ADOS (Autism Diagnosis Observation Scale)	Autistic symptoms (particularly communication and social interaction) measured by standardized scale ADOS (Autism Diagnosis Observation Scale) : comparison of score between folinic acid group and placebo at T0 et after 12 weeks of treatment	change in ADOS scale at 12 weeks
Secondary	Evaluation of the reduction of autistic symptom perceived by parents with a heteroevaluation scale : SRS (social responsiveness scale)	- Evaluation of the reduction of autistic symptom perceived by parents with a heteroevaluation scale : SRS (social responsiveness scale); o Comparison of score between folinic acid group and placebo group at T0 (inclusion) and after 12 weeks of treatment	Change in SRS at 12 weeks
Secondary	evaluate the constancy of auto antibodies anti-FRa	Serum dosage of auto antibodies anti-FRa at T0 and at 12 weeks to evaluate the constancy of auto antibodies anti-FRa	change of auto antibodies anti-FRa at 12 weeks